The purpose of this study is to develop an auto-injector (AI) device for the BMS-986036 subcutaneous formulation that can be self-administered conveniently by participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Specified dose on specified days
Anaheim Clinical Trials
Anaheim, California, United States
ICON (LPRA) - Salt Lake
Salt Lake City, Utah, United States
Maximum observed serum concentration (Cmax)
Time frame: Up to 29 days
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to 29 days
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036
Time frame: Up to 29 days
Incidence of adverse events (AEs)
Time frame: Up to 115 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 85 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 85 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 85 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 85 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 85 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 85 days
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Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 85 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
The PR interval is the time from the onset of the P wave to the start of the QRS complex.
Time frame: Up to 85 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Time frame: Up to 85 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
The QT interval on the ECG is measured from the beginning of the QRS complex to the end of the T wave
Time frame: Up to 85 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Corrected QT interval using Fridericia's formula (QTcF)
Time frame: Up to 85 days
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 85 days
Number of participants with local injection site reactions
Time frame: Up to 57 days
Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)
Time frame: Up to 57 days
Number of participants with Antibodies to BMS-986036
Time frame: Up to 57 days